Type 2 Diabetes Mellitus
Conditions
Interventions
investigational material(s)
Generic name etc : BMS-823778 or placebo
INN of investigational material :
Therapeutic category code : 396 Antidiabetic agents
Dosage and Administration for Investigationa
Sponsors
Bristol-Myers K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: for T2DM patients: - Japanese patients with Type 2 Diabetes Mellitus (Fasting glucose < 240 mg/dL, HbA1c: 6.5% to 10.0% (NGSP)) who are treatment-naive and managed with diet and/or exercises only.
Exclusion criteria
Exclusion criteria: for T2DM patients: - Patient who is taking any medication for T2DM - Symptoms of poorly controlled diabetes that would preclude participation in this placebo-controlled trial - Insulin therapy within one year of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Cmax, Cmin, Tmax, AUC(TAU), AI, T-HALF, %UR, CLT/F, CLR, Cmax/Cmin and T-HALFefff, as measured by plasma/urine concentration of BMS-823778; Pharmacodynamics, as measured by serum concentration of cortisol and cortisone after oral dose of cortisone, and biomarkers for HPA axis activity (urinary free cortisol and cortisone, salivary cortisol, ACTH, DHEA-S, 4-androstenedione) | — |
Outcome results
None listed